Surgical device for use in endoscopic carpal tunnel release (ECTR), endoscopic cubital tunnel release (ECuTR), and endoscopic plantar fasciitis release (EPFR)

ABSTRACT

A disposable, sterile guide constructed of medically-acceptable plastic used for compartmentalizing and therefore protecting the ligament or fascia during three different orthopedic surgical procedures: ECTR, ECuTR, and EPFR. This device reduces the risk of damage to any other part of the surrounding anatomy. The device is disposable and packaged so as to be sterile and therefore readily usable by the surgeon means that it can reduce the risk of infection and is a less expensive alternative to traditional non-disposable, metal instruments that must be sterilized prior to each procedure.

BACKGROUND

Endoscopic Carpal Tunnel Release (ECTR), Endoscopic Cubital TunnelRelease (ECuTR), and Endoscopic Plantar Fasciitis Release (EPFR) arethree surgical procedures used to relieve symptoms in the hand, elbow,and heel, respectively. During each procedure, the surgeon makes a smallincision and inserts a thin tube called an endoscope with a tiny cameraattached to it to view the affected area. The surgeon then inserts acutting instrument through this same, single portal to perform theprocedure. The benefit of endoscopic procedures is that they requiresmaller incisions, leading to the diminution of early post-operativepain, decreasing the amount of recovery time, and expediting patients'return to regular activity. These smaller incisions, however, inherentlymean that visualization of the affected area is more restricted ascompared to procedures such as Open Carpal Tunnel Release (OCTR), duringwhich one large incision is employed. Throughout the history ofendoscopic procedures, surgeons have worked to improve methods ofvisualization in order to improve safety levels and outcomes.

Current guides for surgery are usually stainless steel and come in twopieces, which means there are sterility issues between surgeries andalso the ever-present risk of the pieces becoming unattached in surgicalcontexts. This is especially true because current scope pieces engageone another in a friction attachment.

SUMMARY OF THE EMBODIMENTS

The device described herein is a disposable, sterile guide constructedof medically-acceptable plastic used for compartmentalizing andtherefore protecting the ligament or fascia during three differentorthopedic surgical procedures: ECTR, ECuTR, and EPFR. This devicereduces the risk of damage to any other part of the surrounding anatomy.The fact that the device is disposable and packaged so as to be sterileand therefore readily usable by the surgeon means that it can reduce therisk of infection and is a less expensive alternative to traditionalnon-disposable, metal instruments that must be sterilized before eachprocedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a dilator used to prepare a surgical area for the device.

FIGS. 2A and 2B show side and elevation views of the device.

FIGS. 3A-3D show an alternate embodiment of the device.

FIGS. 4A-4C show a further alternate embodiment of the device.

FIG. 5 shows another alternate embodiment of the device.

FIGS. 6A and 6B show blade and tool variants used with the device.

FIGS. 7 and 8 show side and top views of a further alternate embodimentof a guide device.

FIG. 8A is a cross section through 8A-8A shown in FIG. 8.

FIGS. 9 and 10 show side and top views of a blade.

FIG. 10A is a cross section through 10A-10A shown in FIG. 10.

FIGS. 10, 11, 12A, 12B, and 13 show combinations of the blade anddevice, as well as a camera, in use.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following surgical description may be employed for using thesurgical device shown in the figures in at least three differentsurgeries: Endoscopic Carpal Tunnel Release (Hand), Endoscopic CubitalTunnel Release (Elbow), and Endoscopic Plantar Fasciitis Release (Heel).

After making an incision, the surgeon may use a dilator 10 (FIG. 1) todilate the surgical area. The dilator may be about 6 inches long andtaper at a broader end 14 to a narrow end 12 from 6 mm to 4 mm. Thedilator may include hand grips 16 marked to minimize slipping.

To make room for the guide device to fit atop and below the targetedligament or fascia, the surgeon may insert the device 100, 300, 400 inorder to compartmentalize the ligament or fascia. The surgeon may thenuse the endoscope that has been inserted through a cameral passage orhole to visualize the ligament or fascia area to ensure that there areno other parts of the anatomy, such as nerves or tendons, obstructingthe incision path.

If the incision path is clear, the surgeon can either antegrade cut orretrograde cut the ligament or fascia in a safe environment by insertingthe knife through the appropriate slot, because the device or guide hashelped the surgeon to compartmentalize the ligament or fascia to beincised, isolating it from other parts of the anatomy that couldotherwise be in jeopardy of being inadvertently cut.

The endoscopic camera and the knife may work independently of each otherinside the guide, making it safer for the surgeon to look ahead of theknife when needed.

FIG. 1 is a drawing of the surgical device 100 for assistance inendoscopic surgical procedures, especially those discussed above but notnecessarily limited thereto.

The surgical device 100 may be 100 mm in length, 8 mm wide, andconstructed from ABS plastic. The device 100 may be hollow andcylindrical with 3 mm-thick plastic prongs 110 separated by a 2 mm gap130. FIG. 2 shows one end of the device 100, which is closed with theexception of three holes: the upper and lower circular holes 140 may beeach 2.5 mm in diameter, may be used for the endoscopic camera, and maybe located on either side of the 5 mm long slot 150 used for the knife.The location of the upper and lower circular holes 140 on either side ofthe slot 150 gives the surgeon the ability to use the endoscopic camerato visualize the surgical field more comprehensively from many anglesbefore a cut is made to avoid damaging other portions of the anatomy.

FIGS. 6A and 6B show tools like the knife (600) and wire 605 for usewith the device 100, 300, or 400. In use, a surgeon may grasp the knife600 or wire 605 by a handle 610 that may include finger cutouts for athumb 612 and fingers 614. The tool 600, 605 may comprise both a handleportion 610 and working portion 620. On the knife 600, the workingportion 620 is sized to fit within the slot 150, 380 and includes ablade 630 for performing the incisions as the blade moves within theslot 150, 380.

The wire tool 605 operates similarly to the knife tool 600 except thatits working end 620 includes a narrow wire end 635 for removing finetissue or moving a nerve out of the way of a later incision by the knifetool 600. The wire end 635 may extend in any direction (upwards towardsthe viewer as shown in FIG. 6B being on alternative) but importantlyfits within the knife slot.

The guide device 100 may include a wedge-shaped protrusion 160 at aterminal end of one (or both) of the prongs 110 that may help inclearing tissue from within the gap 130. The wedge may be sharp, extendonly from the narrow terminal end 115 of the prongs 110 or extend acrossthe width of the prong 110.

FIGS. 3A-3D show an alternate embodiment of the device from FIG. 2. Ascan be seen in FIG. 3A, the device 300 includes prongs 310 separated bya gap 330 similar to the geometry of FIGS. 1 and 2. The device 300'sprongs 310 have a narrow terminal end 315 opposite a head portion 320having finger cutouts 340 that in combination help in grasping thedevice 300. This head portion 320 helps in device 300 insertion into thepatient as well as removal, and also positioning the device 300 duringsurgery.

The head portion end face 325 has a tool opening 350 therein. The toolopening 350 passes through the head portion 320 and is in fluidcommunication with the gap 330. The tool opening may include a cameraopening 360 and a blade slot 380 separated by an open space 370 thatallows for a small tool insertion to remove unwanted tissue or otherwaste from the scope or camera opening.

The camera opening is for scope insertion, and allows the surgeon toinspect the incision, ensure the area to be incised is clear of nerves,and generally allow the surgeon to see the work to be performed. As canbe best seen in FIG. 4B, the camera may travel within one of the prongs310 within a camera groove 312 formed along and within each prong 310. Asecond groove 314 may also include room for the tools 600, 605.

The guide device 400 in FIGS. 4A-C is similar to the one in FIGS. 3A-3Dexcept for finger grooves 490. These finger grooves 490 extend into thehead portion 420 and serve two purposes: First, they act to help asurgeon grasp the guide 400 during insertion, when slipping tools can bea problem. Second the finger grooves 490 help with cooling the device400 during manufacture, allowing for uniform cooling and thus, decreasedefect formation.

FIG. 5 shows a further alternate design of the device 500. Within thisdevice, a shelf 565 extends to divide the camera opening halves 560 a,and 560 b. This helps support the scope when inserted into the cameraopenings.

FIGS. 7 and 8 show an alternate embodiment of the guide device 700. Thedevice has two prongs 710 that extend from a head portion 720. At aterminal end 715 of each prong 710, an engaging tooth 717 protrudes intothe gap 730. The teeth 717 in practice may better engage tissue andprevent movement of the guide 700 during surgery. The teeth 717 also mayprevent unwanted ingress of surrounding tissue into the gap 730, whichimproves visibility in the gap and also may prevent unnecessary tissuedamage. The teeth 717 are preferably shaped with rounded edges toprevent catching on tissue.

The guide head portion 720 may include finger cutouts or portions 740 toassist a user in manipulating the guide 700, and these finger portionsmay extend from four sides of the guide to allow for easy manipulation.

It should be appreciated that similar to the guide 400 in FIG. 4C, theguide 700 of FIGS. 7-13 may include channels 712 within its prongs 710for receiving the blade cutting tool 900 and/or camera 1210.

As best seen in FIGS. 8 and 8A, a tool opening 750 extends from the headportion 720 end face 725 and joins one or the other of the channels 712.The tool opening 750 has a blade slot 780 and a camera opening 760. Thecamera opening may be split by a guide portion 765 that acts as astabilizer for the camera 1210 (see FIGS. 12A, 12B, and 13) extendinginto the gap 730.

FIGS. 9, 10, and 10A show an embodiment of the blade cutting tool 900that includes a blade portion 910 and handle 920. The blade portion 910has a cutting blade 930 for cutting tissue. The V-shape cutting blade930 may be used, or a straight blade is possible. The material for thecutting blade may be any durable material not subject to fracture orchipping, with stainless steel being a preferred material due to itsdurability.

The handle 920, which may be some hardened plastic or formable materialthat may be sterile, may be grasped around its exterior perimeter 921,which may include finger cutout portions (not shown) to promote easiergrasping. The handle 920 may include a blade receiving slot 922 thatreceives the blade 910 securely in the handle 920. The blade 910 may besecured to the handle 920 shortly after forming the handle such that ithardens around the blade 910, or the blade 910 may be press fit into thehandle 920. As shown in FIG. 10A, the blade portion 910 includes ahandle engagement end 932 that engages the handle 920, and in particularin a molded configuration where the handle 920 engages the handleengagement end 932 during the molding process, contains blade cutouts934 to better-secure the blade portion 910 to the handle portion 920.

The handle 920 includes handle camera opening 924 separated by a slotdivider 925. The handle camera openings 924 receive an endoscopic camera1210 with an optical end 1220 that serves as the optics for apractitioner. The camera 1210 extends through the handle camera opening924 into the guide camera opening 760, as shown in FIGS. 12A, 12B, and13. The slot divider 925 guides and stabilizes the camera 1210. In use,the camera 1210, blade cutting tool 900, and guide 700 can all moveindependently of one another, which allows for better visibility (camera1210), cutting accuracy (cutting tool 900) and tissue engagement (guide700), as a practitioner moves each one during a surgery.

FIGS. 11-13 show the blade 910 entering the blade receiving slot 780,extending into the gap 730 and stopping when the blade cutting tool 900bottom face 929 engages the guide 700 top face 725. FIG. 12A shows theblade 910 and camera 1210 in phantom within the guide 700.

The device guide described herein may be shipped in sterile packaging toensure sterility in use, which overcomes the issues with certain steelguides that must be sterilized on each use. Because it is plastic, thedevice may be discarded after use and easily replaced, thus making itless expensive than a stainless-steel tool but also safer. Similarly,the blade shown in FIGS. 9-13 may be steel but in such a small quantity,may also be discarded.

In use, the device may encompass the transverse ligament thereforeavoiding the challenge of synovium and fat dropping into view whencutting the ligament. This improves visibility because the surgeon isn'tcutting underneath the ligament but encapsulating the ligament andcutting either antegrade or retrograde and seeing the ligament with atop view as well as bottom view while cutting.

Further, the top and bottom portions of the guide encompass the ligamentand that makes the guide safer for ECTR.

As shown herein, the guide is as a unitary construction molded inplastic, although it is possible to 3D print the guide as well.Multi-piece construction is possible and may be advantageous in certaincontexts.

The device is also made to accommodate both left and right hand for sameprocedure by just turning it upside down to always cut on the ulnar safeside of the hand, which is the ulnar side of anatomy.

While the invention has been described with reference to the embodimentsabove, a person of ordinary skill in the art would understand thatvarious changes or modifications may be made thereto without departingfrom the scope of the claims.

The invention claimed is:
 1. A surgical guide comprising: a headcomprising a tool opening therethrough; and two prongs attached to thehead, each prong including a tooth extending into a gap separating theprongs, wherein the prongs are of equal length and width such thattissue above one prong could not fall into the lower prong, wherein theprongs and head are a unitary molded piece; a surgical cutting toolcomprising: a blade portion including a cutting blade; and a handleportion attached to the blade portion; wherein the blade portion isshaped to fit within a blade slot and extend into the gap between theprongs; wherein the handle portion has a bottom face that contacts aguide end face of the head of the surgical guide to prevent the bladeportion from extending further into the gap; wherein the gap separatingthe prongs is in fluid communication with the tool opening in the head;wherein the tool opening in the head comprises the blade slot and twocamera openings, either one of the camera openings configured to receivea camera; wherein the camera opening in the handle of the surgicalcutting tool is configured to receive an endoscopic camera that extendsthrough one of the camera openings in the surgical guide and into thegap.
 2. The surgical guide of claim 1, wherein the head includes fingercutouts to assist in holding the guide.
 3. The surgical guide of claim1, wherein at least one of the two prongs have a terminal end that isnarrower than a prong end near the head.
 4. The surgical guide of claim1, wherein the tool opening is a single opening that includes the bladeslot and the two camera openings.
 5. The surgical guide of claim 1,wherein the tool opening comprises the two camera openings separated bya divider.
 6. The surgical guide of claim 1, wherein the guide is madefrom ABS plastic.
 7. The surgical guide of claim 1, wherein each prongincludes an open channel that faces an open channel in the other prong,wherein the open channels are together configured to receive the cuttingblade and one or the other of the channels receive the endoscopiccamera.
 8. A surgical guide and surgical cutting tool comprising: thesurgical guide comprising: a head comprising a tool openingtherethrough; and two prongs attached to the head wherein the prongs areof equal length and width such that tissue above one prong could notfall into the lower prong, wherein the prongs and head are a unitarymolded piece; wherein a gap separating the prongs is in fluidcommunication with the tool opening in the head; wherein the toolopening in the head comprises a blade slot and two camera openings,either one of the camera openings configured to receive a camera; andthe surgical cutting tool comprising: a blade portion including acutting blade; and a handle portion attached to the blade portion;wherein the blade portion is shaped to fit within the blade slot andextend into the gap between the prongs; wherein the handle portion has abottom face that contacts a guide end face of the head of the surgicalguide to prevent the blade portion from extending further into the gap;wherein a camera opening in the handle portion of the surgical cuttingtool is configured to receive an endoscopic camera that extends throughone of the camera openings in the surgical guide and into the gap. 9.The surgical guide and surgical cutting tool of claim 8, wherein thecamera opening in the surgical cutting tool and the surgical guidecamera openings are in fluid communication with each other.
 10. Thesurgical guide and surgical cutting tool of claim 8, wherein the prongseach include teeth extending into the gap.
 11. The surgical guide andsurgical cutting tool of claim 8, wherein the head includes fingercutouts to assist in holding the guide.
 12. The surgical guide andsurgical cutting tool of claim 8, wherein at least one of the two prongshave a terminal end that is narrower than a prong end near the head. 13.The surgical guide and surgical cutting tool of claim 8, wherein thetool opening is a single opening that includes the blade slot and thetwo camera openings.
 14. The surgical guide and surgical cutting tool ofclaim 8, wherein the tool opening comprises the two camera openingsseparated by a divider.
 15. The surgical guide and surgical cutting toolof claim 8, wherein the guide is made from ABS plastic.
 16. The surgicalguide and surgical cutting tool of claim 8, wherein the blade portionand the handle portion are joined together during molding.
 17. Thesurgical guide and surgical cutting tool of claim 8, wherein each prongincludes an open channel that faces an open channel in the other prong,wherein the open channels are together configured to receive the cuttingblade and one or the other of the channels receive the endoscopiccamera.
 18. A surgical guide and surgical cutting tool comprising: thesurgical guide comprising: a head comprising a tool openingtherethrough; and two prongs attached to the head wherein the prongs areof equal length and width such that tissue above one prong could notfall into the lower prong, wherein the prongs and head are a unitarymolded piece; wherein a gap separating the prongs is in fluidcommunication with the tool opening in the head; wherein the toolopening in the head comprises a blade slot and two camera openings,either one of the camera openings configured to receive a camera; andthe surgical cutting tool comprising: a blade portion including acutting blade; and a handle portion attached to the blade portion;wherein the blade portion is shaped to fit within the blade slot andextend into the gap between the prongs; wherein the handle portion has abottom face that contacts a guide end face of the head of the surgicalguide to prevent the blade portion from extending further into the gap;wherein an endoscopic camera extends through a camera opening in thehandle portion of the surgical cutting tool through one of the cameraopenings in the surgical guide, and into the gap.